A Study to Evaluate the Safety and Tolerability of AZD7442 in Healthy Chinese Adults
NCT ID: NCT05437289
Last Updated: 2023-03-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
61 participants
INTERVENTIONAL
2021-10-09
2023-01-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
TRIPLE
Study Groups
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300 mg AZD7442 IM
Administration of a single dose of 300 mg AZD7442 (150 mg AZD8895 and 150 mg AZD1061) sequentially by intramuscular (IM) injection.
AZD7442 IM
In cohort 1, participants will be randomized to receive 300 mg AZD7442 (150 mg AZD8895 and 150 mg AZD1061) administered sequentially as direct gluteal IM injections.
300mg placebo IM
Administration of placebo with dose match to AZD7442 in the same cohort sequentially by intramuscular (IM) injection.
Placebo IM
In cohort 1, participants will be randomized to receive placebo with dose match to AZD7442 in the same cohort administered sequentially as direct gluteal IM injections.
600 mg AZD7442 IM
Administration of a single dose of 600 mg AZD7442 (300 mg AZD8895 and 300 mg AZD1061) sequentially by intramuscular (IM) injection.
AZD7442 IM
In cohort 2, participants will be randomized to receive 600 mg AZD7442 (300 mg AZD8895 and 300 mg AZD1061) administered sequentially as direct gluteal IM injections.
600mg placebo IM
Administration of placebo with dose match to AZD7442 in the same cohort sequentially by intramuscular (IM) injection.
Placebo IM
In cohort 2, participants will be randomized to receive placebo with dose match to AZD7442 in the same cohort administered sequentially as direct gluteal IM injections.
300 mg AZD7442 IV
co-administration of a single dose of 300 mg AZD7442 (150 mg AZD8895 and 150 mg AZD1061) by intravenous (IV) infusion.
AZD7442 IV
In cohort 3, participants will be randomized to receive 300 mg AZD7442 (150 mg AZD8895 and 150 mg AZD1061) mixed in IV bag co-administered as a single IV infusion.
300mg placebo IV
co-administration of a single dose of placebo in equivalent volume by intravenous (IV) infusion.
Placebo IV
In cohort 3, participants will be randomized to receive placebo with dose match to AZD7442 in the same cohort as a single IV infusion.
600 mg AZD7442 IV
co-administration of a single dose of 600 mg AZD7442 (300 mg AZD8895 and 300 mg AZD1061) by intravenous (IV) infusion.
AZD7442 IV
In cohort 4, participants will be randomized to receive 600 mg AZD7442 (300 mg AZD8895 and 300 mg AZD1061) mixed in IV bag co-administered as a single IV infusion.
600mg placebo IV
co-administration of a single dose of placebo in equivalent volume by intravenous (IV) infusion.
Placebo IV
In cohort 4, participants will be randomized to receive placebo with dose match to AZD7442 in the same cohort as a single IV infusion.
Interventions
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AZD7442 IM
In cohort 1, participants will be randomized to receive 300 mg AZD7442 (150 mg AZD8895 and 150 mg AZD1061) administered sequentially as direct gluteal IM injections.
Placebo IM
In cohort 1, participants will be randomized to receive placebo with dose match to AZD7442 in the same cohort administered sequentially as direct gluteal IM injections.
AZD7442 IM
In cohort 2, participants will be randomized to receive 600 mg AZD7442 (300 mg AZD8895 and 300 mg AZD1061) administered sequentially as direct gluteal IM injections.
Placebo IM
In cohort 2, participants will be randomized to receive placebo with dose match to AZD7442 in the same cohort administered sequentially as direct gluteal IM injections.
AZD7442 IV
In cohort 3, participants will be randomized to receive 300 mg AZD7442 (150 mg AZD8895 and 150 mg AZD1061) mixed in IV bag co-administered as a single IV infusion.
Placebo IV
In cohort 3, participants will be randomized to receive placebo with dose match to AZD7442 in the same cohort as a single IV infusion.
AZD7442 IV
In cohort 4, participants will be randomized to receive 600 mg AZD7442 (300 mg AZD8895 and 300 mg AZD1061) mixed in IV bag co-administered as a single IV infusion.
Placebo IV
In cohort 4, participants will be randomized to receive placebo with dose match to AZD7442 in the same cohort as a single IV infusion.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Healthy by medical history, physical examination, and baseline safety laboratory tests
3. Negative results of both SARS-CoV-2 qRT-PCR and serology tests within 14 days prior to randomisation.
4. Contraceptive within 365 days post dosing
Exclusion Criteria
* Known hypersensitivity to monoclonal antibody (mAb) or investigational product (IP) component.
* Acute illness including fever on the day prior to or day of dosing.
* Any other significant disease increase the risk to participant study.
2. Laboratory related:
* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> upper limit of normal (ULN), or alkaline phosphatase (ALP) or TBL (total bilirubin) \> 1.5 × ULN
* Serum creatinine \> ULN
* Haemoglobin \< lower limit normal (LLN)
* Platelet count \< LLN
* White blood cell or neutrophil count outside normal reference ranges
* Other laboratory significantly abnormal in the screening panel that, in the opinion of the investigator, will increase participants risk or might confound analysis of study results.
18 Years
55 Years
ALL
Yes
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
Guangzhou, , China
Research Site
Shanghai, , China
Countries
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Other Identifiers
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D8850C00007
Identifier Type: -
Identifier Source: org_study_id
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